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Trial registered on ANZCTR


Registration number
ACTRN12611000432910
Ethics application status
Approved
Date submitted
21/04/2011
Date registered
27/04/2011
Date last updated
24/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Amlamax (made from Indian gooseberry) on raising good cholesterol.
Scientific title
A Pilot Clinical Study to Evaluate the Potential of AMLAMAX (trademark (TM)) (Emblica Officinalis) Extract on Raising HDL-Cholesterol levels and Decreasing Plasma Amyloid beta Levels in subjective memory complainers with low HDL-C.
Secondary ID [1] 260040 0
Nil
Universal Trial Number (UTN)
U1111-1120-9548
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
'Subjective Memory function' 265700 0
Cardiovascular risk factors with metabolic syndrome such as hypertension, Obesity, dyslipidemia 265701 0
Alzheimer's Disease. 265734 0
Low high density lipoprotein cholesterol (HDL-C). 265735 0
Condition category
Condition code
Neurological 265838 265838 0 0
Alzheimer's disease
Alternative and Complementary Medicine 265839 265839 0 0
Herbal remedies
Public Health 265840 265840 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nutritional therapy using a standardised amla extract from Indian gooseberry in raising HDL-C i.e. good cholesterol and decreasing beta amyloid, the main protein involved in the pathogenesis of Alzheimer's Disease.

Duration: A randomized double-blind-placebo-control study for a period of 6 months.

Mode of administration: oral administration.

Dose: Ingestion of 2 x 500 mg AmlamaxTM capsules /Placebo (1g/day total).
Intervention code [1] 264458 0
Treatment: Other
Intervention code [2] 264459 0
Prevention
Intervention code [3] 264460 0
Lifestyle
Comparator / control treatment
A randomized double-blind-placebo-control study will be performed for a period of 6 months. Eligible subjects will be divided in two groups, an experimental group consuming the supplement AmlamaxTM and a control group consuming a placebo capsules. the main component for the placebo capsules is starch.

Group I – Ingestion of 2 x 500 mg AmlamaxTM capsules (1g/day total), one in the morning and one at bed time with a glass of water.
Group II - Ingestion of 2 x 500 mg placebo capsules (1g/day total) one in the morning and one at bed timewith a glass of water.
The placebo capsules will be identical in size and look to the AmlamaxTM capsules.
Control group
Placebo

Outcomes
Primary outcome [1] 266597 0
Raise high density lipoprotein cholesterol.

Lipid Analysis
Blood samples will be sent to a certified medical laboratory (PathWest, Perth, Western Australia) for determination of lipid concentrations (i.e. Total Cholesterol, LDL-C, HDL-C and Triglycerides).
Timepoint [1] 266597 0
baseline (0) months, 2 months, 4 months and 6 months.
Primary outcome [2] 266598 0
Decrease in beta amyloid levels.

A sensitive double-antibody sandwich ELISA assay will be used for the detection and measurement of amyloid beta 40 and Amyloid beta 42 levels in the plasma.
Timepoint [2] 266598 0
baseline (0) month, 2 months, 4 months and 6 months.
Secondary outcome [1] 276090 0
NIL
Timepoint [1] 276090 0
NIL

Eligibility
Key inclusion criteria
Inclusion Criteria: The eligibility criteria will be as follows: 1) age 35-65 years, 2) HDL-C levels <1.03 mMol/L in men or <1.29 mMol/L in women 3) triglyceride (TG) levels >1.7 mMol/L.

psychometric testing using standardized, validated diagnostic tools.
Mini-Mental State Examination (MMSE) score greater than or equal to 24.
2. The classification of SMC will be obtained from a single question, yes/no response from the CAMDEX-R (Do you have any difficulty with your memory?
2.A score greater than or equal to 80-81 (CAMCOG)-R (cognitive component of the CAMDEX-R).
4. a score of below, equal and above age and education norms on the California Verbal Learning Test (CVLT).
Minimum age
35 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients suffering from heart failure, chronic liver disease, eGFR<60 ml/min.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A randomized double-blind-placebo-control study will be performed for a period of 6 months. Eligible subjects will be divided in two groups, an experimental group consuming the supplement AmlamaxTM and a control group consuming a placebo .

Allocation will invove by contacting the holder of allocation schedule who is at central administration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomisation table from a statistic book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264928 0
Hospital
Name [1] 264928 0
Hollywood Private Hospital
Address [1] 264928 0
Monash Avenue
Nedlands
WA, 6009.
Country [1] 264928 0
Australia
Funding source category [2] 264929 0
University
Name [2] 264929 0
Edith Cowan University
Address [2] 264929 0
270 Joondalup Drive
Joondalup
WA 6027
Country [2] 264929 0
Australia
Primary sponsor type
Individual
Name
Prof Ralph Martins
Address
Center of Excellence in Alzheimer's Disease Research and Care
School of Excercise, Biomedical and Health Science
Edith Cowan University
270 Joondalup Drive
Joondalup
WA 6027
Country
Australia
Secondary sponsor category [1] 264028 0
Commercial sector/Industry
Name [1] 264028 0
Arjuna Natural Extracts LTD, Kerala, India.
Address [1] 264028 0
PB 126 Bank Road
Alwaye
Kerala, India
683 101
Country [1] 264028 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266886 0
Hollywood Private Hospital Ethics Committee
Ethics committee address [1] 266886 0
Monash Avenue
Nedlands
WA 6009
Ethics committee country [1] 266886 0
Australia
Date submitted for ethics approval [1] 266886 0
Approval date [1] 266886 0
Ethics approval number [1] 266886 0
HPH 300
Ethics committee name [2] 266897 0
Edith Cowan University
Ethics committee address [2] 266897 0
270 Joondalup Drive
Joondalup
WA 6027
Ethics committee country [2] 266897 0
Australia
Date submitted for ethics approval [2] 266897 0
Approval date [2] 266897 0
Ethics approval number [2] 266897 0

Summary
Brief summary
Several evidence support the notion that increase in total plasma cholesterol, low-density lipoprotein-cholesterol (LDLC), and decreased high-density lipoprotein-cholesterol (HDL-C) are risk factors for cardiovascular disease (CVD). Epidemiological studies have reported that high concentrations of HDL-C or "good" cholesterol (>1.5mMol/L) may also be protective against Alzheimer’s disease (AD).

“AmlamaxTM” developed by the R&D lab of Arjuna Natural Extracts Limited (Kerala, India) is a dry extract from fresh fruits of Amla, which has shown remarkable results in increasing HDL-C levels. Therefore, the objectives of this proposed study will be to explore the effectiveness of the herbal extract AmlamaxTM on raising HDL cholesterol levels in population of subjects with low HDL-C levels drawn from the Perth memory cohort study, as well as to determine whether directly raising HDL-C levels can result in a decrease in plasma beta amyloid levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32520 0
Address 32520 0
Country 32520 0
Phone 32520 0
Fax 32520 0
Email 32520 0
Contact person for public queries
Name 15767 0
Prof Ralph Martins
Address 15767 0
Centre of Excellence for Alzheimer's disease research and Care
School of Exercise, Biomedical and Health Sciences
Edith Cowan University, Joondalup
270 Joondalup Drive, Joondalup, WA, 6027
Country 15767 0
Australia
Phone 15767 0
+61 8 6304 5456
Fax 15767 0
+61 8 6304 5851
Email 15767 0
r.martins@ecu.edu.au
Contact person for scientific queries
Name 6695 0
Professor Ralph Martins
Address 6695 0
Centre of Excellence for Alzheimer's disease research and Care
School of Exercise, Biomedical and Health Sciences
Edith Cowan University, Joondalup
270 Joondalup Drive, Joondalup, WA, 6027
Country 6695 0
Australia
Phone 6695 0
+61 8 6304 5456
Fax 6695 0
+61 8 6304 5851
Email 6695 0
r.martins@ecu.edu.au

No information has been provided regarding IPD availability
Summary results
No Results